OUTPATIENT ORAL SULINDAC TO PREVENT RECURRENCE OF PRETERM LABOR

Objective: To assess the efficacy and safety of oral sulindac in preve nting the recurrence of preterm labor. Methods: This was a randomized, double-blind, placebo-controlled study of patients between 24-34 week s' gestation with preterm labor treated with intravenous magnesium sul fate. After successful tocolysis, patients were randomized by the phar macy to receive either oral sulindac (200 mg) or placebo (once orally every 12 hours) for 7 days. Results: Sixty-nine patients were enrolled 84 in the sulindac group, 35 controls). No significant differences we re found with respect to time gained in utero (40 +/- 4.4 versus 31 +/ - 3.4 days, P = .1), delivery at more than 35 weeks' gestation (20 ver sus 18, P = .70), recurrent preterm labor (11 versus 13, P = .88), bir th weight (2528 +/- 646 versus 2459 +/- 707 g, P = .68), or time spent in the neonatal intensive care unit (4.2 +/- 12.9 versus 5.7 +/- 13.5 days, P = .63) for the sulindac and control groups, respectively. How ever, in women who failed therapy tie, those who delivered before 37 w eeks' gestation or required readmission for tocolysis), there was a si gnificantly longer interval between the start of therapy and failure i n the sulindac group (25.9 +/- 3.4 days, n = 26) than in the control g roup (15.2 +/- 2.8 days, n = 25; P < .05). Conclusion: The use of oral sulindac for 1 week after successful parenteral tocolysis failed to r educe the overall rate of preterm birth. In women who delivered premat urely or required readmission for tocolysis, oral sulindac significant ly prolonged the interval from the start of therapy until delivery or readmission. Moreover, this benefit was achieved without observable ad verse effects on the fetus.